Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

Official title

A Randomized, Partially Blinded, Dose-Exploratory, Active/Placebo-Controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of the Adsorbed Acellular Pertussis (Tricomponent) DPT-Hib (Conjugate)-ACYW135-Group B Meningococcal (Conjugate) Combined Vaccine in Individuals Aged 2 Months to 6 Years

Overview

This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine/placebo groups.

Interventions

• Biological Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)
  1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
• Biological DTcP-Hib-MCV4
  1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
• Biological DTcP-Hib-MCV4
  1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
• Biological DTcP-Hib-MCV4
  3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
• Biological DTcP-Hib-MCV4
  3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
• Biological Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)
  3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
• Biological Haemophilus influenzae type b (Conjugate) (Hib)
  3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
• Biological Meningococcal Group ACYW135 (Conjugate) (MCV4)
  3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
• Biological MCV4
  3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
• Biological MCV4
  3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.

Primary outcome measures

• Incidence of adverse reactions [Time frame: Parts I and II: Within 14 days after each dose]

Secondary outcome measures (12)

• Incidence of adverse events [Time frame: Part I Sections 1A, 2A, 2B: Within 14 days after exemption]
• Incidence of adverse events [Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 14 days after each dose]
• Incidence of adverse reactions/events [Time frame: Part I Sections 1A, 2A, 2B: Within 30 minutes after exemption]
• Incidence of adverse reactions/events [Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 minutes after each dose]
• Incidence of adverse reactions/events [Time frame: Part I Sections 1A, 2A, 2B: Within 30 days after exemption]
• Incidence of adverse reactions/events [Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 days after each dose]
• Incidence of Serious Adverse Event (SAE) [Time frame: Part I Sections 1A, 2A, 2B: Within 180 days after exemption]
• Incidence of Adverse Event of Special Interest (AESI) [Time frame: Part I Sections 1A, 2A, 2B: Within 180 days after exemption]
• Incidence of Serious Adverse Event (SAE) [Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose]
• Incidence of Adverse Event of Special Interest (AESI) [Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose]
• Abnormal laboratory test values [Time frame: Part I Sections 1A, 2A, 2B: 4 days after exemption]
• Seroconversion Rate of A, C, Y, W135 Group Meningococcal Antibody [Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination]

Eligibility criteria

Inclusion criteria

General Inclusion Criteria:

• Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years of age, with legal guardians or authorized representatives willing to provide identification documentation;
• Legal guardians or authorized representatives provide informed consent, voluntarily sign the informed consent form, and are able to comply with the requirements of the clinical trial protocol;

Part I: Specific Inclusion Criteria:

• Individuals aged 18-24 months who have completed a 3-dose DTaP-containing vaccine series and a meningococcal-containing vaccine primary series, but have not received a DTaP-containing booster dose;
• Individuals aged 6 years who have completed 4 doses of DTaP-containing vaccine but have not received the 5th DTaP-containing vaccine dose; and have only completed the first meningococcal-containing vaccine booster dose, without receiving the second meningococcal-containing vaccine booster dose at age 6.

Exclusion criteria

General Exclusion Criteria for First Dose：

• Infants born prematurely (delivery before 37 weeks gestation) or with low birth weight (<2500g) at 2 months (60-89 days) or 3 months (90-119 days) of age;
• Infants aged 2 months (60-89 days) or 3 months (90-119 days) with history of abnormal labor, asphyxia requiring resuscitation, or neurological impairment;
• Severe congenital malformations or developmental disorders, genetic defects, or severe malnutrition;
• History of severe adverse reactions or anaphylaxis to vaccines or vaccine components, such as urticaria, dyspnea, angioedema;
• History of epilepsy, convulsions, seizures, cerebral palsy, psychiatric disorders, or family history thereof; or history of progressive neurological diseases (e.g., Guillain-Barré syndrome, brachial plexus neuritis);
• Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;
• Acute illness (e.g., fever ≥38.5°C, diarrhea) or acute exacerbation of chronic disease within 3 days prior to receiving the investigational product;
• Known or suspected severe chronic diseases (including: severe respiratory disease, severe cardiovascular disease, liver/kidney disease, severe dermatology conditions, malignancies, etc.);
• Current anal abscess or severe eczema;
• Clinically diagnosed coagulation disorders (e.g., factor deficiency, bleeding disorders, platelet abnormalities) or significant bruising/coagulation impairment;
• Asplenia, functional asplenia, or splenectomy due to any cause;
• Continuous treatment with immunosuppressants, immunomodulators, or cytotoxic agents (exceeding 10 days) within the past 6 months; inhaled or topical steroids are permitted;
• Receipt of blood products or immunoglobulins (excluding hepatitis B immunoglobulin) within the past 3 months;
• Received an injectable live attenuated vaccine within 14 days, or any other vaccine within 7 days;
• Taken antipyretic analgesics or antiallergic medications within 3 days;
• Fever present prior to vaccination, with axillary temperature ≥37.3°C (99.3°F);
• Plans to participate in or is currently participating in any other drug/vaccine clinical trial;
• Any other factors deemed by the investigator to make the subject unsuitable for participation in the clinical trial.

Part I: Exclusion Criteria for the First Dose：

• Infants aged 2 months (60-89 days) who have received vaccines containing meningococcal, DTP, or Haemophilus influenzae type b components;
• Infants aged 3 months (90-119 days) who have received a vaccine containing meningococcal components;
• Individuals aged 18-24 months who have received vaccines containing meningococcal or Haemophilus influenzae type b components within the past six months;
• Individuals aged 18-24 months with abnormal pre-vaccination blood count or urinalysis results deemed clinically significant by the investigator;
• Children aged 6 years who, prior to vaccination, exhibit abnormal results in relevant indicators of complete blood count, blood biochemistry, coagulation function, or urinalysis, and are deemed clinically significant by the investigator;
• Individuals with a history of any of the following diseases: meningococcal meningitis, Haemophilus influenzae type b disease, pertussis, diphtheria, or tetanus.

Part II: Specific Exclusion Criteria for the First Dose

• History of vaccination with any meningococcal-containing vaccine;
• History of meningococcal disease. General Exclusion Criteria for Subsequent Doses：
• Occurrence of a serious adverse event related to vaccination following the previous dose;
• Vaccine-related Grade 3 or higher allergic reaction following the previous dose;
• Any other factors deemed by the investigator to make the subject unsuitable for continued participation in the clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Liangyuan District Center for Disease Control and Prevention, Shangqiu City — Shangqiu

Identifiers

NCT: NCT07203755 · CTP-DHMCV-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗